External Bone Fixation Device

ABSTRACT

The present application discloses embodiments related to an external bone fixation device configured to correct bone deformities or repair bone injuries. The device can include a plurality of bases configured to be attached to portions of a bone and a plurality of struts configured to be adjustable in length to change the position and orientation of the plurality of bases and the attached bone portions.

CROSS-REFERENCE TO RELATED APPLICATIONS

This application is a divisional of U.S. application Ser. No. 13/800,319filed Mar. 13, 2013. U.S. application Ser. No. 13/800,319 is related bysubject matter to U.S. application Ser. No. 13/800,545 filed Mar. 13,2013, which issued Oct. 21, 2014 as U.S. Pat. No. 8,864,763. The abovedisclosures are hereby incorporated by reference as if set forth intheir entireties herein.

TECHNICAL FIELD

The present application relates generally to orthopedics. Morespecifically, the present application relates to a device and method forthe repair of fractures or deformities in long bones.

BACKGROUND

External bone fixation devices are used to stabilize bone segments andto facilitate the healing of bones at a bone repair site. A bone repairsite can include a location of a deformity in a bone or an area ofinjury to a bone. Distraction and reduction/compression devices may beincorporated into an external bone fixation device and may be used togradually adjust the relative orientation and spacing of portions of thebone on opposite sides of a bone repair site.

An external bone fixation device can include a number of support membersconfigured to be connected to the portions of the bone on opposite sidesof the bone repair site, as well as a number of distraction andreduction/compression devices configured to adjust the distance betweenthe support members of the external bone fixation device that areattached to the bone portions on opposite sides of the bone repair site.The distraction devices are configured to move the support membersgradually over a determined amount of time. The gradual separationallows new bone to form in the void of the bone repair site. In othercases, reduction or compression across a bone repair site to hold thebone portions together is desired to facilitate healing. Suchadjustments, whether distraction or reduction/compression, typicallyfollow a prescribed protocol, or treatment plan. After each adjustment,the distraction and reduction/compression device is typically held fixedfor a time allowing the new bone to grow and gain strength. After thebone repair site has healed, the external bone fixation device isremoved from the bone portions.

SUMMARY

Various embodiments and methods of an external bone fixation device (andthe components of the external bone fixation device) used to stabilizebone segments and to facilitate the healing of bones at a bone repairsite are disclosed. In one embodiment, the device includes a strutconfigured to be connected to a pair of external bone fixation membersalong a strut axis. The strut includes a strut body having a threadedrod and a sleeve. The threaded rod includes a rod body that is elongatealong the strut axis. The rod body defines an outer surface that is atleast partially threaded, and the sleeve includes a sleeve body and abore that extends at least into the sleeve body. The bore is configuredto receive at least a portion of the threaded rod such that the threadedrod is translatable relative to the sleeve along the strut axis. Thestrut further includes an actuator supported by the strut body andthreadedly attached to the threaded rod, such that rotation of theactuator relative to the rod about the strut axis translates at leastone or both of the rod and the sleeve relative to the other of the rodand the sleeve along the strut axis. The strut further includes alocking mechanism supported by the strut body so as to be pivotalrelative to the strut body about a pivot axis between a lockedconfiguration whereby the locking mechanism prevents the actuator fromrotating relative to the threaded rod, and an unlocked configurationwhereby the locking mechanism does not prevent the actuator fromrotating relative to the threaded rod, and the pivot axis is angularlyoffset with respect to the strut axis.

In another embodiment, a strut configured to be connected to a pair ofexternal bone fixation members along a strut axis includes a strut bodyhaving a threaded rod and a sleeve, the threaded rod including a rodbody that is elongate along the strut axis, and the rod body defining anouter surface that is at least partially threaded. The sleeve has asleeve body and a bore that extends at least into the sleeve body, thebore configured to receive at least a portion of the threaded rod suchthat the threaded rod is translatable relative to the sleeve along thestrut axis. The strut further includes an actuator supported by thestrut body and threadedly attached to the threaded rod, such thatrotation of the actuator relative to the rod about the strut axistranslates at least one or both of the rod and the sleeve relative tothe other of the rod and the sleeve along the strut axis. The actuatorincludes a gripping member that is configured to receive a torque thatrotates the actuator relative to the threaded rod about the strut axis.The gripping member includes a body and a bore that extends through thebody, the body having an inner surface that at least partially definesthe bore and an outer surface opposite the inner surface. The bore isconfigured to at least partially receive the strut body, and thegripping member further includes a projection that is fixed to thegripping member body and extends out from the outer surface of thegripping member body in a direction away from the inner surface of thegripping member body.

In another embodiment, a strut configured to be connected to a pair ofexternal bone fixation members along a strut axis includes a strut bodyhaving a threaded rod and a sleeve, the threaded rod including a rodbody that is elongate along the strut axis, and defines an outer surfacethat is at least partially threaded. The sleeve includes a sleeve bodyand a bore that extends at least into the sleeve body, the boreconfigured to receive at least a portion of the threaded rod such thatthe threaded rod is translatable relative to the sleeve along the strutaxis. The strut further includes an actuator supported by the strut bodyand threadedly attached to the threaded rod, such that rotation of theactuator relative to the rod about the strut axis translates at leastone or both of the rod and the sleeve relative to the other of the rodand the sleeve along the strut axis. The strut further includes a jointconfigured to attach to one of the external bone fixation members, thejoint including a first hinge body supported by the threaded rod, asecond hinge body configured to attach to the external bone fixationmember, and a cross coupling member configured to couple the first hingebody to the second hinge body such that first hinge body is rotatablerelative to second hinge body about both a first axis that is angularlyoffset with respect to the strut axis, and a second axis that isangularly offset with respect to both the first axis and the strut axis.Wherein the cross coupling member is substantially spherical.

In another embodiment, a strut configured to be connected to a pair ofexternal bone fixation members along a strut axis includes a strut bodyhaving a threaded rod and a sleeve, the threaded rod including a rodbody that is elongate along the strut axis and defines an outer surfacethat is at least partially threaded. The sleeve includes a sleeve bodyand a bore that extends at least into the sleeve body, and the bore isconfigured to receive at least a portion of the threaded rod such thatthe threaded rod is translatable relative to the sleeve along the strutaxis. The strut further includes an actuator supported by the strut bodyand threadedly attached to the threaded rod, such that rotation of theactuator relative to the rod about the strut axis translates at leastone or both of the rod and the sleeve relative to the other of the rodand the sleeve along the strut axis. The strut further includes alocking mechanism supported by the strut body so as to be pivotalrelative to the strut body about a pivot axis between a lockedconfiguration whereby the locking mechanism prevents the actuator fromrotating relative to the threaded rod in response to an applied torque,and an unlocked configuration whereby the locking mechanism does notprevent the actuator from rotating relative to the threaded rod inresponse to the applied torque. Wherein the locking mechanism includes alever the lever that defines a first surface, and the strut body definesa second surface that interferes with the first surface so as to preventrotation of the actuator relative to the threaded rod about the strutaxis when the locking mechanism is in the locked configuration, thefirst and second surfaces oriented such that the first and secondsurfaces do not cam over one another in response to the applied torque.

In another embodiment, a strut configured to be connected to a pair ofexternal bone fixation members along a strut axis includes a threadedrod having a rod body that is elongate along the strut axis, the rodbody defining an outer surface that is at least partially threaded. Thestrut further has a sleeve including a sleeve body, the sleeve bodydefining an inner surface that defines a bore that extends at least intothe sleeve body and is configured to receive a portion of the rod body.The strut further having an actuator threadedly attached to the threadedrod and rotatably supported by the sleeve. Wherein one of the innersurface and the rod body supports a track that is elongate along adirection parallel to the strut axis, and the other of the inner surfaceand the rod body fixedly supports a follower configured to ride alongthe track such that the treaded rod translates with respect to thesleeve along the strut axis when the actuator is rotated with respect tothe sleeve and the threaded rod.

In another embodiment, a method of assembling an external bone fixationdevice configured to repair a deformity in a bone is disclosed. Thedevice includes a strut having a first joint, a second joint, and alength measured from the first joint to the second joint along a strutaxis. The first and second joints define first and second fastenerreceiving holes respectively, and the strut further includes an actuatorconfigured to adjust the length and a locking mechanism configured to besupported by the actuator. The locking mechanism includes a lockedconfiguration in which the actuator is prevented from adjusting thelength, and an unlocked configuration in which the actuator is able toadjust the length. The first and second external bone fixation memberseach include a top surface and a bottom surface. The first and secondexternal fixation members each further including a fastener receivinghole extending from the top surface to the bottom surface, and the firstexternal fixation member defines a center and a radial outward directionthat extends from the center to the fastener receiving hole of the firstexternal bone fixation member.

The method includes the step of positioning the strut relative to thefirst external bone fixation member such that the fastener receivinghole of the first joint is aligned with the fastener receiving hole ofthe first external fixation member. The method further includes the stepof inserting a first fastener into and at least partially through thefastener receiving hole of the first joint and the fastener receivinghole of the first external bone fixation member. The method furtherincludes the step of rotating the actuator about the strut axis suchrelative to the fastener receiving hole of the first external bonefixation member such that the locking member is spaced from the strutaxis in the radial outward direction. The method further includes thestep of positioning the strut relative to the second external bonefixation member such that the fastener receiving hole of the secondjoint is aligned with the fastener receiving hole of the second externalfixation member. The method further includes the step of inserting asecond fastener into and at least partially through the fastenerreceiving hole of the second joint and the fastener receiving hole ofthe second external bone fixation member, such that after the step ofinserting of the second fastener through the fastener receiving holes ofthe second external fixation member and the second joint, the actuatoris not rotatable relative to the fastener receiving hole of the firstexternal bone fixation member about the strut axis when the lockingmechanism is in the locked configuration.

BRIEF DESCRIPTION OF THE DRAWINGS

The foregoing summary, as well as the following detailed description ofillustrative embodiments of the external bone fixation device of thepresent application, will be better understood when read in conjunctionwith the appended drawings. For the purposes of illustrating theexternal bone fixation device of the present application, there is shownin the drawings illustrative embodiments. It should be understood,however, that the application is not limited to the precise arrangementsand instrumentalities shown. In the drawings:

FIG. 1A is a perspective view of an external bone fixation device in afirst configuration, positioned proximate a fractured bone, the externalbone fixation device including a plurality of bases and a plurality ofstruts;

FIG. 1B is a perspective view of the external bone fixation deviceillustrated in FIG. 1A in a second configuration positioned proximatethe fractured bone;

FIG. 2A is a perspective view of one of the plurality of basesillustrated in FIG. 1A, according to one embodiment;

FIG. 2B is a top plan view of the base illustrated in FIG. 2A;

FIG. 3 is a perspective view of one of the plurality of basesillustrated in FIG. 1A, according to another embodiment;

FIG. 4 is a top plan view of one of the plurality of bases illustratedin FIG. 1A, according to another embodiment;

FIG. 5A is a perspective view of one of the plurality of strutsillustrated in FIG. 1A, according to one embodiment, the strut includingan actuator, a threaded rod, a sleeve, a first joint, and a secondjoint;

FIG. 5B is a top plan view of the strut illustrated in FIG. 5A;

FIG. 5C is a cross-sectional side view of the strut illustrated in FIG.5B along line 3B-3B;

FIG. 6A is an exploded perspective view of the strut illustrated in FIG.5;

FIG. 6B is an exploded, cross-sectional view of the strut illustrated inFIG. 7A;

FIG. 7A is a perspective view of a gripping member of the actuatorillustrated in FIG. 5A;

FIG. 7B is a side elevation view of the gripping member illustrated inFIG. 7A;

FIG. 7C is a top plan view of the gripping member illustrated in FIG.7A;

FIG. 7D is a front elevation view of the gripping member illustrated inFIG. 7A;

FIG. 8A is a perspective view of the strut illustrated in FIG. 5A, thestrut including a distraction nut, a drive nut, and a clamp in a firstposition;

FIG. 8B is a perspective view of the actuator illustrated in FIG. 8A,with the clamp in a second position;

FIG. 9A is a perspective view of the actuator illustrated in FIG. 5A;

FIG. 9B is a cross-sectional view of the strut illustrated in FIG. 9A;

FIG. 10A is a perspective view of the strut illustrated in FIG. 5A, in asecond configuration;

FIG. 10B is a cross-sectional view of the strut illustrated in FIG. 10A.

DETAILED DESCRIPTION OF ILLUSTRATIVE EMBODIMENTS

Certain terminology is used in the following description for convenienceonly and is not limiting. The words “right”, “left”, “lower”, “upper”,“bottom”, and “top” designate directions in the drawings to whichreference is made. The words, “anterior”, “posterior”, “superior”,“inferior”, “medial”, “lateral” and related words and/or phrasesdesignate preferred positions and orientations in the human body towhich reference is made. For example, the words “medially” and“laterally” refer to directions toward and away from, respectively, amidline extending vertically through a body. The words “proximal” and“distal” refer to directions toward or away from where an appendage,such as a leg, is joined to the rest of the body, respectively. Theterminology includes the above-listed words, derivatives thereof andwords of similar import.

The term “plurality”, as used herein, means more than one. When a rangeof values is expressed, another embodiment includes from the oneparticular value and/or to the other particular value. Similarly, whenvalues are expressed as approximations, by use of the antecedent“about,” it will be understood that the particular value forms anotherembodiment. Further, reference to values stated in ranges includes eachand every value within that range. All ranges are inclusive andcombinable. Certain features of the invention which are described hereinin the context of separate embodiments may also be provided incombination in a single embodiment. Conversely, various features of theinvention that are described in the context of a single embodiment mayalso be provided separately or in any subcombination.

A three dimensional coordinate system is used to describe the positionsand orientations of the parts of the external bone fixation device. Thecoordinate system includes a first direction, such as a longitudinaldirection L; a second direction, such as a lateral direction A, and athird direction, such as a transverse direction T, wherein each of thedirections is perpendicular to both of the other two directions.

Referring to FIGS. 1A and 1B, an external bone fixation device 20 isconfigured to be used to correct bone deformities, which can beanatomical deformities or bone injuries such as fractures. In oneembodiment the external bone fixation device 20 can be used to treat afractured long bone 2, such as a femur. The bone 2 can include a firstbone portion 4, such as a proximal portion, and a second bone portion 6,such as a distal portion. The first bone portion 4 and the second boneportion 6 can be separated by a defect, such as a fracture 8. The device20 is configured to attach to the bone 2 at a first location 10 locatedon the first bone portion 4, and at a second location 12 located on thesecond bone portion 6. The device 20 is configured to move at least oneor both of the first bone portion 4 and the second bone portion 6relative to the other of the first bone portion 4 or the second boneportion 6, respectively, from a first position, such as a firstorientation as shown in FIG. 1A, to a second position that is differentfrom the first position, such as a second orientation different from thefirst orientation as shown in FIG. 1B, to align the first and secondbone portions 4 and 6 so as to assist in correction the bone deformityof the bone 2.

As shown in the illustrated embodiment, the device 20 can include aplurality (e.g., a pair or more) of external bone fixation members, suchas bases 22, that are each configured to be secured to respective boneportions, and at least one strut 24, such as a plurality of struts 24,that are configured to attach to at least a pair of the external bonefixation members at attachment locations 23. Fasteners 14, for examplebolts or screws, can be used to secure the strut 24 relative to the base22 at the attachment location 23. The external support members canattach to a bone fixation element 204 that is anchored in the respectivebone portion. For instance, the external support member can be supportedoutboard of the epidermis that surrounds the bone portion, and the bonefixation element 204 can extend from the external support member,through the epidermis and soft tissue disposed between the epidermis andbone portion, and into the bone portion.

For example, the bases 22 can include a first base 22 a and a secondbase 22 b. The struts 24 can define respective distraction andreduction/compression devices (collectively referred to herein as“strut” or “struts” 24) configured to attach adjacent ones of theplurality of bases 22 such that the adjacent bases 22 are movablerelative to one another. For instance, the struts 24 define a lengthbetween the attachment locations 23 that can be adjustable so as tocause at least one of the bases 22 to move relative to the other of thebases 22 at the respective attachment locations 23.

In particular, an increase of the length of the struts 24 can cause oneof the attachment locations 23 to move away from the other of theattachment locations, a decrease of the length of the struts 24 cancause one of the attachment locations 23 to move toward the other of theattachment locations 23, and any adjustment of the length (increase ordecrease) can cause at least one of the external fixation members torotate relative to the other of the external fixation members. Each ofthe struts 24 includes a first end portion 26 configured to be attachedto a first of the adjacent bases 22, for example the first base 22 a atthe attachment location 23, and a second end portion 28 configured to beattached to a second of the adjacent bases 22, for example the secondbase 22 b at the attachment location 23. The struts 24 can furtherinclude a strut axis 72 (as shown in FIG. 5A), the strut axis 72 extendsfrom the first end portion 26 to the second end portion 28 such that thestrut 24 is elongate along the strut axis 72.

The strut 24 includes an intermediate portion 30 disposed between thefirst end portion 26 and the second end portion 28. The strut 24 canfurther include an actuator 32, such that when the actuator 32 isactuated, the first end portion 26 moves relative to the second endportion 28. In one embodiment, the intermediate portion 30 carries orsupports the actuator 32, as shown. Actuation, for example rotation, ofthe actuator 32 of the strut 24 moves the first end portion 26 relativeto the second bone portion 28. When the first end portion 26 is attachedto the first base 22 a and the second end portion 28 is attached to thesecond base 22 b, actuation of the actuator 32 moves the first endportion 26 and the attached first base 22 a relative to the second endportion 28 and the attached second base 22 b.

The device 20 is configured such that in an assembled configuration,wherein the first end portions 26 and the second end portions 28 of thestruts 24 are attached to the first base 22 a and the second base 22 b,the first base 22 a is moveable relative to the second base 22 b in upto six degrees of freedom. For example, the first base 22 a cantranslate relative to the second base 22 b in either theanterior-posterior direction AP, the medial-lateral direction ML, thesuperior-inferior direction SI, or any combination thereof. In addition,the first base 22 a can rotate relative to the second base 22 b about anaxis defining the anterior-posterior direction AP, the medial-lateraldirection ML, the superior-inferior direction SI, or any combinationthereof.

The rotational locking of the strut 24 when attached to one of the bases22 at both the first and second end portions 26 and 28 may be desired inan application where a certain orientation of the struts 24 relative tothe bases 22 is desired. For example, the struts 24 can include visualindications regarding the properties of the strut 24, such as thecurrent length of the strut. The rotational locking of the strut 24 asdescribed above allows a user to have the visual indications facing in adirection that are easily readable by a user when the external bonefixation device 20 is attached to the bone 2.

The device 20, in one embodiment, includes a plurality of attachmentmechanisms 200 that are configured to attach the first bone portion 4 tothe first base 22 a and the second bone portion 6 to the second base 22b such that as the first and second bases 22 a and 22 b move relative toone another, the first and second bone portions 4 and 6 also moverelative to one another. In other words the attachment mechanisms 200are configured to attach a base 22 to a portion of the bone 2 such thatthe base 22 and the portion of the bone 2 are translationally androtationally coupled together.

As shown in the illustrated embodiment, the attachment mechanisms 200can include a bracket 202 that can be attached to the base 22, forexample by a fastener 206. The attachment mechanism 200 further includesthe bone fixation element 204 that couples the bracket 202 to the bone2. The bone fixation element 204 includes, for example, a wire 208 and arod 210. In one embodiment, the wire 208 is a Kirschner wires (or“K-wire”). As shown, the wire 208 is configured to be attached to afirst bracket 202 a, extend completely through the bone 2, and beattached to a second bracket 202 b on the other side of the bone 2. Therod 210 is configured to be attached to a bracket 202, and extend into,or partially through, the bone 2. As shown, the rod 210 is only attachedto one bracket 202. The rod 210 can be threaded or have anotherretention structure on an end of the rod 210 that is inserted into thebone 2 that aids in securing the rod 210 to the bone 2.

Referring to FIGS. 2A and 2B, the base 22 includes a base body 34. Asshown in the illustrated embodiment, the base body 34 can besubstantially ring shaped. The base body 34 can be formed from amonolithic piece of material, as shown, or the base body 34 can beformed from separate pieces or segments of material that are joinedtogether. The base 22 can include a base axis 36. In one embodiment, thebase axis 36 is a central axis such that the base body 34 issubstantially centered about the base axis 36. The base body 34 includesa first surface 38 (or upper surface), a second surface 40 (or lowersurface) that is opposite the first surface 38, and a thickness T1measured from the first surface 38 to the second surface 40. In oneembodiment the thickness T1 is constant throughout the base body 34. Inanother embodiment the thickness T1 is not constant throughout the basebody 34.

As shown in the illustrated embodiment, the first surface 38 issubstantially planar such that the first surface 38 defines a plane P1.In another embodiment, the second surface 40 is substantially planarsuch that the second surface 40 defines the plane P1. In anotherembodiment both the first surface 38 and the second surface 40 aresubstantially planar such that either the first surface 38 or the secondsurface 40, or both define the plane P1.

Referring to FIGS. 1A to 2B, the device 20 includes more than one base22. As shown, the device includes the first base 22 a and the seconddevice 22 b. The first base 22 a and the second base 22 b are configuredto be attached to the first bone portion 4 and second bone portion 6 ofa bone 2, respectively. When the first base 22 a and the second base 22b are first attached to the first and second bone portions 4 and 6, thefirst and second bone portions 4 and 6 are in a first orientationrelative to one another. When the first and second bases 22 a and 22 bare attached to the first and second bone portions 4 and 6 in the firstorientation, the first and second bone portions 4 and 6 are in anundesired position such that the planes P1 of the first and second bases22 a and 22 b are non-parallel to one another, the base axes 36 of thefirst and second bases 22 a and 22 b are non-parallel, or both.

After the first and second bases 22 a and 22 b are secured to the firstand second bone portions 4 and 6 in the first configuration, a treatmentplan can be performed to move the first and second bases 22 a and 22 binto a second orientation. In the second orientation, the first andsecond bone portions 4 and 6 are in a desired position such that theplanes P1 of the first and second bases 22 a and 22 b are substantiallyparallel to one another, the base axes 36 of the first and second bases22 a and 22 b are substantially parallel, or both. As will be describedin detail below, the treatment plan can include actuation of theactuators 32 of the struts 24. In one embodiment the treatment planincludes actuation of the actuators 32 of specified struts 24, aspecified amount, over a specified amount of time.

Referring to FIGS. 2A and 2B, the base body 34 further includes a firstside wall 44, such as an outer side wall, and an inner side wall 46,such as an inner side wall, that is opposite the first side wall 44. Asshown in the illustrated embodiment, the first side wall 44 defines anouter periphery of the base body 34, and the second side wall 46 definesan inner periphery of the base body 34. The base body 34 defines aninner diameter D1 measured from the second side wall 46 at a firstlocation, through the base axis 36, and to the second side wall 46 at asecond location. The base body 34 defines an outer diameter D2 measuredfrom the first side wall 44 at a first location, through the base axis36, and to the first side wall 44 at a second location.

The base 22 can further include an opening 48. The opening 48 is definedby the base body 34, for example the second side wall 46, and theopening 48 is configured to receive the bone 2. The base body 34 definesa width W1 measured from the second side wall 46 to the first side wall44 in a direction perpendicular to the base axis 36. In one embodimentthe width W1 is constant throughout the base body 34. In anotherembodiment the width W1 is not constant throughout the base body 34.

In one embodiment, the base body 34 includes at least one tab 56. Thetab 56 includes a portion of the base body 34 that extends radiallyoutward from the base axis 36 farther than a surrounding portion of thebase body 34. As shown, the tab 56 defines a portion of the base body 34with a greater width W1″ than the width W1′ of the base body 34 at alocation adjacent the tab 56. The base body 34 can include any number oftabs 56 (including no tabs), spaced about the base body 34 in anydesired configuration. For example, the base body 34 can include threetabs 56 spaced apart substantially equally about the outer periphery ofthe base body 34, such that each of the tabs 56 is spaced about 120degrees from each of the other two tabs 56.

The base 22 also includes a plurality of holes 50. The plurality ofholes 50 extend through the base body 34, for example the holes 50extend though an entirety of the thickness T1 of the base body 34 fromthe first surface 38 to the second surface 40. The holes 50 areconfigured to receive the struts 24 and the attachment mechanisms 200.The holes 50 can be threaded, unthreaded, or a combination of threadedand unthreaded such that the holes 50 are configured to receive bothlocking and non-locking fasteners. In the illustrated embodiment, theholes 50 include a first series holes 50 a and a second series of holes50 b. The first series of holes 50 a are arranged such that they arepositioned on the base body 34 along a first circle 52 a. The secondseries of holes 50 b are arranged in the illustrated embodiment, suchthat they are positioned on a second circle 52 b. As shown, the firstcircle 52 a has a smaller diameter than the second circle 52 b.

In one embodiment, the second series of holes 50 b is positioned alongthe second circle 52 b and the second circle 52 b passes through atleast one, for example three, tabs 56. The first and second series ofholes 50 a and 50 b can be positioned within the base body 34 such thata first ray line R1 extending from the base axis 36 to the first sidewall 44 passes through a hole 50 in the first series of holes 50 a and ahole 50 in the second series of holes 50 b. The first and second seriesof holes 50 a and 50 b can further be positioned within the base body 34such that a second ray line R2 extending from the base axis 36 to thefirst side wall 44 passes through a hole 50 in the first series of holes50 a but does not pass through a hole 50 in the second series of holes50 b. The first and second series of holes 50 a and 50 b can stillfurther be positioned within the base body 34 such that a third ray lineR3 extending from the base axis 36 to the first side wall 44 passesthrough a hole 50 in the second series of holes 50 b but does not passthrough a hole 50 in the first series of holes 50 a.

Each of the holes 50 defines a center 54. The holes 50 are arranged suchthat adjacent holes 50 define a distance between their centers 54. Thedistance is referred to hereafter as “chord length C1” for the firstseries of holes 50 a and “chord length C2” for the second series ofholes 50 b. In one embodiment, the first series of holes 50 a arearranged throughout the base body 34 such that the chord length C1′ offirst adjacent holes 50 a′ is different from the chord length C1″ ofsecond adjacent holes 50 a″.

Referring to FIG. 3, in another embodiment the device 20 includes a base122 that defines a base body 134. The base 122 is similar to the base 22in many aspects such that the description of the base 22 above can beapplied to the base 122 except where indicated to the contrary below. Asshown, the base body 134 includes a primary base body 135 a and asecondary base body 135 b. The primary and secondary base bodies 135 aand 135 b are configured to be connected such that they form a completering. In one embodiment the primary base body 135 a defines a partialring, for example about a ⅝ (five-eighths) ring, and the secondary basebody 135 b defines another partial ring, for example a ⅜ (three/eighths)ring that complements the partial ring of the primary base body 135 asuch that when the primary and secondary base bodies 135 a and 135 b arejoined, a complete ring is formed.

The use of a base 122 with segments, for example primary and secondarybase bodies 135 a and 135 b provides additional flexibility or optionswhen the device 20 is being assembled and attached to a patient. Forexample, the primary base body 135 a can be placed in a desired positionrelative to a bone and the secondary base body 135 b can be attached tothe primary base body 135 a in the desired position without having totraverse the base 122 all the way from a distal end of the bone (orappendage) to the desired position.

In another embodiment, the device 20 includes a base 122 that onlyincludes the primary base body 135 a such that the base 122 defines onlya partial ring shape and a gap. The use of a partial ring shape, forexample the primary base body 135 a, can allow added flexibility for apatient that the device 20 is attached to. The primary base body 135 acan be positioned such that the gap is posterior to (or behind) thepatient's knee, allowing the patient's knee to flex without interferencefrom the base body 134.

Referring to FIG. 4, in another embodiment the device 20 includes a base222 that defines a base body 234. The base 222 is similar to the base 22in many aspects such that the description of the base 22 above can beapplied to the base 222 except where indicated to the contrary below. Asshown, the base body 234 includes a primary base body 235 and one ormore legs 236 extending out from the primary base body 235. As shown,the base body 234 includes two legs 236 extending out from the primarybase body 235 such that the legs 236 are substantially parallel to eachother. In another embodiment, the legs 236 extend out from the primarybase body 235 such that the legs 236 are substantially non-parallel toeach other. The base 222 further defines a gap 238 positioned betweenthe legs 236. The base 222 is configured to be placed around anappendage, such as a foot such that the primary base body 235 ispositioned posterior to (or behind) a heel of the foot, and the gap 238is positioned to receive an anterior portion, such as the toes, of thefoot. The use of the base 222 in the device 20 allows a patient to walkafter the device 20 is attached to the patient, for example duringtreatment of a deformity or repair of an injury to the patient's foot.

Referring to FIGS. 5A to 5C, in one embodiment, strut 24 includes astrut body 25, the strut body 25 includes, in one embodiment, a firstmember, for example a threaded rod 60, and a second member, for examplea sleeve 62. The threaded rod 60 and the sleeve 62 are configured to beconnected such that the threaded rod 60 and the sleeve 62 aretranslatable relative to one another. The strut 24 further includes afirst joint 64 configured to be connected to the threaded rod 60, and asecond joint 66 configured to be connected to the sleeve 62. One of thefirst and second joints 64 and 66, for example the first joint 64, canbe a rotatable joint and the other of the first and second joints 64 and66, for example 66, can be a non-rotatable joint, as described ingreater detail below. The strut 24 also includes an actuator 32configured to be coupled to the strut 24, for example supported by thestrut body 25 such that actuation of the actuator 32 translates thethreaded rod 60 relative to the sleeve 62.

The strut 24 includes a first end, such as a proximal end 68, and asecond end, such as a distal end 70. The strut 24 further includes astrut axis 72 extending from the proximal end 68 to the distal end 70.The strut 24, in one embodiment, is elongate along the strut axis 72. Asshown in the illustrated embodiment, the strut axis 72 is a centralaxis, and the strut axis 72 is parallel to the longitudinal direction L.The strut 24 defines a length L1 measured from a first point 73 to asecond point 75 along the strut axis 72. In one embodiment the firstpoint 73 is located at or near the proximal end 68, for example in thefirst joint 64, and the second point 75 is located at or near the distalend 70, for example in the second joint 66. Actuation of the actuator 32translates the threaded rod 60 relative to the sleeve 62, changing thelength L1.

Referring to FIGS. 5A to 6B, the threaded rod 60 includes a first end,for example a rod proximal end 74, a second end, for example a roddistal end 76, and a rod body 78 that extends from the rod proximal end74 to the rod distal end 76 and is elongate in the longitudinaldirection L, or along the strut axis 72. The rod body 78 includes anouter surface 80 that is at least partially threaded. The threaded rod60 defines an outer dimension D3, for example an outer diameter. One endof the threaded rod 60, for example the rod proximal end 74, isconfigured to receive the first joint 64. The strut 24 includes afollower 77. In one embodiment, the follower 77 is supported by the roddistal end 76. The follower 77 is configured to prevent the threaded rod60 from rotating relative to the sleeve 62 as the threaded rod 60translates relative to the sleeve 62. The follower 77 can be in the formof a set screw 79 that is configured to be secured to a set screw hole81 of the threaded rod 60. The set screw 79 includes a head portion 83and a shaft 85 that extends out from the head portion 83. In oneembodiment, the set screw hole 81 is positioned within the rod distalend 76. The rod distal end 76 can include a flat section that isconfigured to receive the set screw 79 such that the head portion 83 ofthe set screw 79 abuts the flat section and the shaft 85 of the setscrew 79 extends through the set screw hole 81 and protrudes out of theset screw hole 81 and at least partially into a track 89 of the sleeve62 as described in detail below.

The sleeve 62 includes a first end, for example a sleeve proximal end82, a second end, for example a sleeve distal end 84, and a sleeve body86 that extends from the sleeve proximal end 82 to the sleeve distal end84 and is elongate in the longitudinal direction L. In one embodiment,the sleeve 62 includes a recess, such as a bore 88 that extends into andat least partially through the sleeve body 86 from the sleeve proximalend, in the longitudinal direction towards the sleeve distal end 84. Thesleeve body 86, as shown, defines a tube-like structure.

The sleeve body 86 includes a sleeve inner surface 90 that defines thebore 88, and a sleeve outer surface 92 that is opposite the sleeve innersurface 90. The sleeve 62 defines an inner dimension D4, such as aninner diameter measured within the bore 88, and an outer dimension D5,such as an outer diameter. The sleeve outer surface 92 includes anengagement mechanism, for example the sleeve proximal end 82 is at leastpartially threaded. The sleeve body 86 can be substantially C-shapedsuch that the sleeve body 86 defines a slot 94. The slot 94 extends inthe transverse direction T from the sleeve outer surface 92 to thesleeve inner surface 90, and the slot 94 extends in the longitudinaldirection L, or along the strut axis 72, between the sleeve proximal end82 and the sleeve distal end 84.

The sleeve 62 can further include a track 89 that is configured toreceive the follower 77 of the threaded rod 60 such that interference ofthe follower 77 and the track 89 prevents rotation of the threaded rod60 relative to the sleeve 62 as the threaded rod 60 translates relativeto the sleeve 62. The track 89 extends into the sleeve body 86 from thesleeve inner surface 90 in a direction toward the sleeve outer surface92. In one embodiment the track 89 does not extend all the way throughthe sleeve body 86. In another embodiment the track 89 is spaced apartfrom the slot 94, for example such that if the slot extends through the“top” of the sleeve 62, the track extends towards the “bottom” of thesleeve 62. In another embodiment the track 89 is at least partiallyaligned with the slot 94.

As shown in the illustrated embodiment, the actuator 32 includes adistraction nut 96, a drive nut 98, and a locking mechanism 104. In oneembodiment, the distraction nut 96 and the drive nut 98 are configuredto be rotationally and translationally coupled to each other, such thatfor example, the as the distraction nut 96 translates along thelongitudinal direction L, the drive nut 98 also translates along thelongitudinal direction L.

The distraction nut 96 includes a gripping member 100, such as anactuator housing 102. In one embodiment, the gripping member 100 carriesthe locking mechanism 104, for example a lever 106, such that as thegripping member 100 moves (for example translates along the longitudinaldirection L or rotates about an axis aligned with the longitudinaldirection L) the locking mechanism 104 moves with the gripping member100. The gripping member 100 is configured to be connected to the sleeve62 such that the gripping member 100 is rotatable, for example about thelongitudinal direction L (or the strut axis 72), relative to the sleeve62.

The locking mechanism 104 is configured to be connected to, or carriedby, the gripping member 100 such that when the locking mechanism is in afirst, or locked, configuration the gripping member 100 is rotationallylocked with respect to the sleeve 62, preventing the gripping member 100from rotating relative to the sleeve 62. The locking mechanism isfurther configured to be connected to or carried by, the gripping member100 such that when the locking mechanism is in a second, or unlockedconfiguration the gripping member 100 is rotatable with respect to thesleeve 62.

Referring to FIGS. 5A to 7D, the gripping member 100 includes a proximalend 108, a distal end 110, and a gripping member body 112 extending fromthe proximal end 108 to the distal end 110. The gripping member body 112includes an outer surface 114 and an inner surface 116 that is oppositethe outer surface 114. The gripping member 100 further includes a bore118 that is at least partially defined by the inner surface 116. Thebore 118 extends into and at least partially through the gripping memberbody 112 from the proximal end 108 to the distal end 110. As shown inthe illustrated embodiment, the bore 118 can include a first portion 160and a second portion 162.

The gripping member 100 defines a first inner dimension D6 measuredwithin the first portion 160 of the bore 118, and a second innerdimension D7 measured within the second portion 162 of the bore 118. Asshown the first and second inner dimensions D6 and D7 can be different,such that the first inner dimension D6 is larger than the second innerdimension D7. The inner surface 116 defining the first portion 160 ispartially threaded in one embodiment. In another embodiment, the innersurface defining the first portion 160 is entirely threaded or entirelyunthreaded.

The outer surface 114 of the gripping member body 112 is partiallycylindrical or a tube-like shape such that the gripping member 100defines an outer dimension D8, for example an outer diameter, measuredfrom a first point on the outer surface 114, through the strut axis 72,to a second point on the outer surface 114 that is opposite the firstpoint. The gripping member 100 can further include at least one groove164 that extends into the gripping member body 112 from the outersurface 114 in a direction toward the inner surface 116 such that thegroove 164 defines a depth E1. The gripping member 100 can includesmultiple grooves 164, as shown, to improve a user's ability to grip andapply a torque to the gripping member 100.

The gripping member 100 can further include a projection 166 that isconfigured to receive a torque applied to the gripping member 100 tomake rotation of the gripping member 100 easier, for example byproviding a mechanical advantage. As shown the projection 166 is in theform of a raised portion 168. The raised portion 168 includes at leastone projection side wall 170, for example two projection side walls,that extends out from the outer surface 114 of the gripping member body112 in a direction away from the inner surface 116 of the grippingmember body 112. The projection 166 defines a height H1 measured fromwhere the projection side wall 170 extends out from the outer surface114 and in the direction that the projection side wall extends away fromthe inner surface 116. In one embodiment, the projection 166 furtherincludes a projection top surface 172 extending between the projectionside walls 170.

As shown in the illustrated embodiment, the outer dimension D8 of thegripping member 100 is measured at a location that does not include theprojection 166. The gripping member 100 further defines an outerdimension D9 measured from the a first point on the outer surface 114,through the strut axis 72, to a second point located on either theprojection side wall 170 or the projection top surface 172. In oneembodiment, the projection 166 is configured such that the height H1 ofthe projection side wall 170 is between about 3 mm and about 9 mm, theouter dimension D8 is between about 15 mm to about 30 mm, and the outerdimension D9 is between about 20 mm and about 35 mm. In anotherembodiment, the projection 166 is configured such that the height H1 ofthe projection side wall 170 is about 6 mm, the outer dimension D8 isabout 22 mm, and the outer dimension D9 is about 27 mm. In anotherembodiment, the projection 166 is configured such that the height H1 ofthe projection side wall 170 is at least 10 percent of the outerdimension D8. In another embodiment, the height H1 of the projectionside wall 170 is at least 20 percent of the outer dimension D8. Inanother embodiment, the height H1 is between about 20 percent and about30 percent of the outer dimension D8.

In one embodiment, the depth E1 is between about 0.5 mm and about 1 mm.In another embodiment the height H1 is at least 5 times greater than thedepth E1. In another embodiment the height H1 is at least 10 timesgreater than the depth E1. In another embodiment the height H1 isbetween about 5 and about 10 times greater than E1. For example, in oneembodiment, the gripping member 100 can define an outer dimension D8 ofabout 22 mm, an outer dimension D9 of about 27 mm, a projection heightH1 of about 6 mm, and a groove depth E1 of about 0.7 mm.

As shown in the illustrated embodiment, the gripping member 100,specifically the projection 166 carries the locking mechanism 104. Theprojection 166 includes a projection body 174 and a recess 176 extendinginto the projection body 174 and terminating at a base surface 177. Therecess 176 is configured to at least partially receive the lockingmechanism 104. The locking mechanism 104 is configured such that in afirst, locked configuration the locking mechanism 104 prevents rotationof the gripping member 100 relative to the sleeve 62. The lockingmechanism 104 is further configured such that in a second, unlockedconfiguration the locking mechanism 104 does not interfere with rotationof the gripping member 100 relative to the sleeve 62.

In one embodiment, the locking mechanism 104 is a lever 106. The lever106 is configured to be pivotally attached to the gripping member 100.The lever 106 includes a pivot axis 178 that the lever 106 pivots aboutfrom the first, locked configuration to the second, unlockedconfiguration. As shown, locking mechanism 104 can include a pin 182.The lever 106 and the gripping member 100, specifically the projection166, each include corresponding through holes 180 a and 180 b,respectively configured to be aligned and receive the pin 182. When thelocking mechanism 104 is pivotally attached to the gripping member 100as described above, the locking mechanism 104 is pivotable from thefirst, locked configuration to the second, unlocked configuration aboutan axis, specifically the pivot axis 178, that is non-parallel to thestrut axis 72. In another embodiment, the locking mechanism 104 ispivotable from the first, locked configuration to the second, unlockedconfiguration about an axis, specifically the pivot axis 178, that issubstantially perpendicular to the strut axis 72.

As shown in the illustrated embodiment the locking mechanism 104includes a locking mechanism body 105 and a biasing member, such as aspring 184. The locking mechanism body 105 includes a base portion 186,a stop portion 188, and the pivot axis 178. The base portion 186 can bepositioned on one side of the pivot axis 178 and the stop portion 188can be positioned on the other side of the pivot axis 178 as shown. Therecess 176 of the projection 166 is further configured such that whenthe locking mechanism body 105 is at least partially received within therecess 176 and the locking mechanism body 105 is pivotally attached tothe gripping member 100, the spring 184 is configured to be receivedwithin the recess 176.

In one embodiment, the spring 184 is configured to be positioned withinthe recess 176 such that the spring 184 is between the base surface 177of the projection 166 and the base portion 186 of the locking mechanismbody 105. The spring 184 can be configured such that when the lockingmechanism body 105 is pivotally attached to the gripping member 100 thespring 184 exerts a biasing force on the base portion 186 of the lockingmechanism body 105 in a direction away from the strut axis 72, forexample in a direction substantially perpendicular to the strut axis 72,such that the locking mechanism 104 is biased towards the first, lockedconfiguration. In one embodiment, the spring 184 is configured to biasthe locking mechanism body 105 into the first, locked configuration evenwhen the strut 24 is under a load, for example during actuation of theactuator 32 to change the length L1 of the strut 24, when the strut 24is attached to a pair of external bone fixation members, such as thebases 22. Application of a greater force to the base portion 186, in theopposite direction of the biasing force pivots the locking mechanismbody 105 about the pivot axis 178 into the second, unlockedconfiguration.

Referring to FIGS. 5A to 6B, the strut 24 can further include a bearing190. The bearing 190 is configured to connect the actuator 32 to thesleeve 62 such that the actuator 32 is translationally fixed relative tothe sleeve 62, and rotatable about the strut axis 72 relative to thesleeve 62. The bearing includes a proximal end 192, a distal end 194,and a bearing body 196 extending from the proximal end 192 to the distalend 194. The bearing 190 further includes a bearing bore 198 extendinginto and at least partially through the bearing body 196 from theproximal end 192 to the distal end 194. The bearing, as shown, includesa first portion 260 and a second portion 262.

The bearing 190 defines a first inner dimension D10 measured within thebearing bore 198 at the first portion 260, and a second inner dimensionD11 measured within the bearing bore 198 at the second portion 262. Asshown the first and second inner dimensions D10 and D11 can bedifferent, such that the first inner dimension D10 is smaller than thesecond inner dimension D11. The bearing body 196 further includes aninner surface 264 and an outer surface 266 that is opposite the innersurface 264. The inner surface 264 at least partially defines thebearing bore 198. The inner surface 264, for example the second portion262, is partially threaded in one embodiment. In another embodiment, theinner surface 264 defining the bearing bore 198 within the secondportion 262 is entirely threaded or entirely unthreaded.

The bearing 190 further defines a first outer dimension D12 defined bythe outer surface 266 measured within the first portion 260, and asecond outer dimension D13 defined by the outer surface 266 measuredwithin the second portion 262. As shown the first and second outerdimensions D12 and D13 can be different, for example the first outerdimension D12 can be smaller than the second outer dimension D13.

The strut 24 can further include a locking feature 268, for example arecess 270 configured to receive the stop portion 188 of the lockingmechanism 104. In one embodiment the recess 270 is defined by thebearing 190. The recess 270 and the stop portion 188, in one embodiment,have corresponding shapes such that when the locking mechanism 104 is inthe first, locked configuration the stop portion 188 is at leastpartially received within the recess 270 preventing any rotation of thelocking mechanism 104 relative to the bearing 190. When the lockingmechanism 104 is in the second, unlocked configuration the stop portion188 is completely removed from the recess 270 such that the lockingmechanism 104 can rotate relative to the bearing 190, for example aboutthe strut axis 72.

Referring to FIGS. 5A to 6B, 8A and 8B, the actuator 32 can furtherinclude a drive nut 98 that is rotationally and translatably lockedrelative to the distraction nut 96. The drive nut 98 is furtherconfigured to engage the threaded rod 60 such that the drive nut 98 isrotatable and translatable relative to the threaded rod 60. As shown inthe illustrated embodiment, the drive nut 98 includes an attachmentportion 272, a collet portion 274, and an intermediate portion 276between the attachment portion 272 and the collet portion 274. Theattachment portion 272 is configured to be secured to the distractionnut 96. For example, the attachment portion 272 can include an outersurface 278 that is at least partially threaded. The threaded outersurface 278 of the attachment portion 272 is configured to engage thethreaded inner surface 116 of the distraction nut 96. When thecorresponding threaded inner surface 116 and threaded outer surface 278are engaged, the distraction nut 96 and the drive nut 98 are securedrelative to one another both translationally and rotationally.

The collet portion 274 of the drive nut 98 is configured to releasablyengage with the threaded rod 60 both rotationally and translatably. Asshown, the collet portion 274 includes a plurality of flexible fingers280, each flexible finger 280 being separated from an adjacent flexiblefinger 280 by a gap 282. Each of the flexible fingers 280 includes aninner surface 284 and an outer surface 286 opposite the inner surface284. The inner surface 284 of the flexible fingers 280 is at leastpartially threaded such that the threaded inner surface 284 of thecollet portion 274 corresponds to the threaded outer surface 80 of thethreaded rod 60.

The collet portion 274 includes an open configuration in which thethreaded inner surface 284 is capable of translating relative to thethreaded rod 60 without rotating the drive nut 98 relative to thethreaded rod 60. In the open configuration, a user is able to makequick, relatively large adjustments to the length L1 of the strut 24 bysimply translating the threaded rod 60 relative to the sleeve 62 withoutthe need to rotate or actuate the actuator 32. The collet portion 274further includes a closed configuration in which the threaded innersurface 284 engages the threaded rod 60 such that the drive nut 98cannot translate relative to the threaded rod 60 without rotating thedrive nut 98 relative to the threaded rod 60.

The drive nut 98 can further include a clamp 288, for instance a ringclamp 290 as shown in the illustrated embodiment. The clamp 288 includesa clamp body 292 and a through hole 294 passing through the clamp body292. The clamp body 292 includes an inner surface 296 that at leastpartially defines the through hole 294. The clamp body 292 furtherdefines an inner dimension D14, for example an inner diameter, that isconfigured such that the clamp 288 is configured to be slidably attachedto the intermediate portion 276 and the collet portion 274. As shown,the intermediate portion 276 or the collet portion 274 is configured topass at least partially through the through hole 294.

Referring to FIGS. 8A and 8B, the clamp 288 is moveable relative to thedrive nut 98 between a first position (as shown in FIG. 8A) and a secondposition (as shown in FIG. 8B), such that in the first position thecollet portion 274 passes at least partially though the through hole294. In the first position the clamp 288 biases or compresses theflexible fingers 280 of the collet portion 274 into the closedconfiguration. In the second position the intermediate portion 276passes at least partially through the through hole 294 such that theclamp 288 does not bias the flexible fingers 280 of the collet portion274 into the closed configuration. In one embodiment, the flexiblefingers 280 of the collet portion 274 are naturally biased into the openconfiguration, such that if the clamp 288 is in the second position, andthus not biasing the flexible fingers 280 into the closed configuration,the collet portion 274 will be in the open configuration allowing thedrive nut 98 to translate freely along the threaded rod 60 withoutrotating the drive nut 98 relative to the threaded rod 60.

In one embodiment, the actuator 32 can be made of a radiolucent materialsuch as a polymer, for example polyether ether ketone (PEEK). Use of aradiolucent material such as PEEK in one or more portions of the strut24 provides a clear radiography image of the bone 2 and other parts ofthe device 20 made from radiopaque materials, which may assist thedevelopment a treatment plan for the external bone fixation device 20 tocorrect a bone defect or repair a bone injury. In another embodiment,any combination of the threaded rod 60, sleeve 62, actuator 32, firstjoint 64, and second joint 66, either in whole or in part is formed froma radiolucent material such as PEEK. In another embodiment, any one ofor any combination of the threaded rod 60, sleeve 62, actuator 32, firstjoint 64, and second joint 66, either whole or in part, is formed from apolyetherimide (PEI), for example Ultem. In another embodiment, any oneof or any combination of the threaded rod 60, sleeve 62, actuator 32,first joint 64, and second joint 66, either whole or in part, is formedfrom a polyoxymethylene (POM), for example Delrin. In anotherembodiment, any one of or any combination of the threaded rod 60, sleeve62, actuator 32, first joint 64, and second joint 66, either whole or inpart, is formed from a polyphenylsulfone (PPSF or PPSU), for exampleRadel. In one embodiment, the locking mechanism 104 can be formed,either in whole or in part, from titanium, titanium alloy, aluminum, oraluminum alloy.

Referring to FIGS. 5A to 6B, the strut 24 further includes the firstjoint 64 and the second joint 66. The first joint 64 is described belowas a non-rotatable joint attached to the threaded rod 60 and the secondjoint 66 is described as a rotatable joint (that includes a shoulder452) attached to the sleeve 62. It should be understood that in oneembodiment, the first (non-rotatable) joint 64 can be attached to thesleeve 62 and the second (rotatable) joint 66 can be attached to thethreaded rod 60. In another embodiment, the strut 24 can include twofirst (non-rotatable) joints 64, one attached to the threaded rod 60 andone attached to the sleeve 62. In another embodiment, the strut 24 caninclude two second (rotatable) joints 66, one attached to the threadedrod 60 and one attached to the sleeve 62.

The first joint 64 is configured to be located at one of the first endand the second end, for example the proximal end 68, of the strut 24 andthe second joint 66 is configured to be located at the other of thefirst end and the second end, for example the distal end 70, of thestrut 24. The first and second joints 64 and 66 are configured to attachthe strut 24 to the first and second bases 22 a and 22 b. The firstjoint 64 includes a first hinge body 300, a second hinge body 302, and across coupling member 304 that is configured to pivotally connect thefirst and second hinge bodies 300 and 302. In one embodiment, the firstjoint 64 includes a fastener receiving hole 350 that extends into and atleast partially through the second hinge body 302. The fastenerreceiving hole 350 is configured to receive a fastener 14 (as shown inFIG. 1A) that is inserted through the fastener receiving hole 50 of thebase 22 and into the fastener receiving hole 350 of the first joint 64to attach the strut 24 to the base 22 at the attachment location 23. Theterm “non-rotatable joint” used herein refers to a joint, for examplethe first joint 64, that is configured such that when the non-rotatablejoint is attached to the base 22, for example by a fastener 14 asdescribed above, the second hinge body 302 does not rotate relative tothe base 22.

The first joint 64, in one embodiment, is configured as a universaljoint such that the first and second hinge bodies 300 and 302 arerotationally coupled about a first axis, and rotatable relative to oneanother about a second axis and a third axis. For example, the first andsecond hinge bodies 300 and 302 are configured to be rotationallycoupled about the strut axis 72 and pivotal relative to one anotherabout a first pivot axis 306 and a second pivot axis 308. In theillustrated embodiment, the first and second pivot axes 306 and 308define a plane that is perpendicular to the strut axis 72. The first andsecond hinge bodies 300 and 302 are rotatable relative to each otherabout any axis that lies in the plane.

The first hinge body 300 includes a base portion 310 and a pair of legs312, extending out from the base portion 310. The legs 312 are spacedapart from one another to define a first gap 314 that is configured toat least partially receive the cross coupling member 304. The secondhinge body 302 includes a base portion 316 and a pair of legs 318,extending out from the base portion 316. The base portion 316 includes abase surface 354 configured to face the base 22 when the first joint 64is attached to the base 22. The second hinge body 302 includes afastener receiving hole 350 extending into the base portion 316. Thesecond hinge body 302 can include threads 356 such that the fastenerreceiving hole 350 is threaded. In one embodiment, fastener receivinghole 350 is threaded along its entire length, such that the threads 356abut the base surface 354 with no gap between the threads 356 in thefastener receiving hole 350 and the base surface 354. The legs 318 arespaced apart from one another to define a second gap 320 that isconfigured to at least partially receive the cross coupling member 304.

The pair of legs 312 and 318 of both the first and second hinge bodies300 and 302 can further include an attachment feature configured tosecure the cross coupling member 304 within the first and second gaps314 and 320. As shown, the pair of legs 312 of the first hinge body 300includes a first pin hole 322 configured to receive a first pin 324, andthe pair of legs 318 of the second hinge body 302 includes a second pinhole 326 configured to receive a second pin 328.

The cross coupling member 304 includes a body 330 that is configured tobe at least partially received between the first and second gaps 314 and320. In one embodiment, the body 330 is substantially spherical. Inanother embodiment the cross coupling member 304 is made from a firstmaterial and the first and second hinge bodies 300 and 302 are made fromsecond material that is different from the first material. The firstmaterial can be more radiopaque than the second material. For example,the cross coupling member 304 can be made from titanium and the firstand second hinge bodies 300 and 302 can be made from aluminum. The shapeof the substantially spherical body 330 and the difference in materialsbetween the cross coupling member 304 and the first and second hingebodies 300 and 302 can improve the use of radiography, such as x-rays,to plan a treatment plan using the external bone fixation device 20 tocorrect a bone defect or repair a bone injury. For example, thesubstantially spherical body 330 will appear as a circle (orsubstantially as a circle) in an x-ray taken from any angle about theexternal bone fixation device. Forming the cross coupling member 304from a more radiopaque material than the first and second hinge bodies300 and 302 will result in the cross coupling member appearing brighteron the x-ray than the surrounding structure.

The cross coupling member 304 further includes a first pin hole 332, thefirst pin 324, a second pin hole 334, and the second pin 328. The firstpin hole 332 of the cross coupling member 304 is configured to receivethe first pin 324 when the first pin hole 332 is aligned with the firstpin hole 322 of the first hinge body 300. The second pin hole 334 of thecross coupling member 304 is configured to receive the second pin 328when the second pin hole 334 is aligned with the second pin hole 326 ofthe second hinge body 302. As shown the first and second pin holes 332and 334 of the cross coupling member 304 pass through one another, forexample at about a 90 degree angle. One of the first and second pinholes 332 and 334 can be larger than the other of the first and secondpin holes 332 and 334, such that the larger of the pin holes 332 and 334is configured to receive a larger one of the first and second pins 324and 328. For example, the second pin hole 334 and the second pin 328 canbe larger than the first pin hole 332 and the first pin 324. The secondpin hole 334 can include a cross hole 336 that is configured to bealigned with the first pin hole 332 and receive the first pin 324.

The first hinge body 300 is configured to be coupled to the threaded rod60, such that the threaded rod 60 and the first hinge body 300 aretranslationally and pivotally coupled to each other. In one embodiment,the base portion 310 of the first hinge body 300 includes a recess 338that is configured to at least partially receive the rod proximal end 74of the threaded rod 60, and a pin 342. The rod body 78 and the baseportion 310 can include matching pin holes 341 a and 341 b configured tobe aligned and then receive the pin 342. Once the pin 342 is insertedthrough the aligned matching pin holes 341 a and 341 b, the threaded rod60 and the first joint 64 are translationally and rotationally coupledwith respect to one another. Although the first hinge body 300 and thethreaded rod 60 are shown as separate parts that are releasable andcoupleable to each other, in another embodiment, the first hinge body300 and the threaded rod 60 can be formed from a single piece ofmaterial, or monolithically formed.

The second joint 66 includes a first hinge body 400, a second hinge body402, and a cross coupling member 404 that is configured to pivotallyconnect the first and second hinge bodies 400 and 402. In oneembodiment, the second joint 66 includes a fastener receiving hole 450that extends into and at least partially through the second hinge body402. The fastener receiving hole 450 is configured to receive a fastener14 (as shown in FIG. 1A) that is inserted through the fastener receivinghole 50 of the base 22 and into the fastener receiving hole 450 of thesecond joint 66 to attach the strut 24 to the base 22 at the attachmentlocation 23. The term “rotatable joint” used herein refers to a joint,for example the second joint 66, that is configured such that when therotatable joint is attached to the base 22, for example by a fastener 14as described above, the second hinge body 402 is rotatable relative tothe base 22.

The second joint 66, as shown in the illustrated embodiment, isconfigured as a universal joint such that the first and second hingebodies 400 and 402 are rotationally coupled about a first axis, androtatable relative to one another about a second axis and a third axis.For example, the first and second hinge bodies 400 and 402 areconfigured to be rotationally coupled about the strut axis 72 andpivotable relative to one another about a first pivot axis 406 and asecond pivot axis 408. In the illustrated embodiment, the first andsecond pivot axes 406 and 408 define a plane that is perpendicular tothe strut axis 72. The first and second hinge bodies 400 and 402 arerotatable relative to each other about any axis that lies in the planedefined by the first and second pivot axes 406 and 408.

The first hinge body 400 includes a base portion 410 and a pair of legs412, extending out from the base portion 410. The legs 412 are spacedapart from one another to define a first gap 414 that is configured toat least partially receive the cross coupling member 404. The secondhinge body 402 includes a base portion 416 and a pair of legs 418,extending out from the base portion 416. The base portion 416 includes abase surface 454 configured to face the base 22 when the second joint 66is attached to the base 22. The second hinge body 402 includes afastener receiving hole 450 extending into the base portion 416 from thebase 454 in a direction toward the pair of legs 418 such that thefastener receiving hole 450 defines a length. The second hinge body 402can further include threads 456 such that the fastener receiving hole450 is threaded. In one embodiment, fastener receiving hole 450 isthreaded along a portion of its length, such that the threads 456 do notabut the base surface 454. Instead a shoulder 452 (for example in theform of a gap or unthreaded portion) is positioned between the threads456 in the fastener receiving hole 450 and the base surface 454. Theshoulder 452 is configured such that when the second hinge 66 isattached to the base 22, the second hinge 66 is rotatable relative tothe base 22. The legs 418 are spaced apart from one another to define asecond gap 420 that is configured to at least partially receive thecross coupling member 404.

The pair of legs 412 and 418 of both the first and second hinge bodies400 and 402 can further include an attachment feature configured tosecure the cross coupling member 404 within the first and second gaps414 and 420. As shown, the pair of legs 412 of the first hinge body 400includes a first pin hole 422 configured to receive a first pin 424, andthe pair of legs 418 of the second hinge body 402 includes a second pinhole 426 configured to receive a second pin 428.

Similarly to the cross coupling member 304 of the first joint 64described above, the cross coupling member 404 of the second joint 66,in one embodiment, includes a body 430 that is configured to be at leastpartially received between the first and second gaps 414 and 420. Thebody 430, as shown, is substantially spherical and can be made from afirst material, for example titanium, and the first and second hingebodies 400 and 402 can be made from second material, for examplealuminum, that is different from the first material. The shape of thesubstantially spherical body 430 and the choice of materials for thecross coupling member and the first and second hinge bodies 400 and 402can be selected to improve the use of radiography, such as x-rays, toplan a treatment plan using the external bone fixation device 20 tocorrect a bone defect or repair a bone injury.

The cross coupling member 404 further includes a first pin hole 432, thefirst pin 424, a second pin hole 434, and the second pin 428. The firstpin hole 432 of the cross coupling member 404 is configured to receivethe first pin 424 when the first pin hole 432 is aligned with the firstpin hole 422 of the first hinge body 400. The second pin hole 434 of thecross coupling member 404 is configured to receive the second pin 428when the second pin hole 434 is aligned with the second pin hole 426 ofthe second hinge body 402. As shown the first and second pin holes 432and 434 of the cross coupling member 404 pass through one another, forexample at about a 90 degree angle. One of the first and second pinholes 432 and 434 can be larger than the other of the first and secondpin holes 432 and 434, such that the larger of the pin holes 432 and 434is configured to receive a larger one of the first and second pins 424and 428. For example, the second pin hole 434 and the second pin 428 canbe larger than the first pin hole 432 and the first pin 424. The secondpin hole 434 can include a cross hole 436 that is configured to bealigned with the first pin hole 432 and receive the first pin 424.

The first hinge body 400 is configured to be coupled to the sleeve 62,such that the sleeve 62 and the first hinge body 400 are translationallyand pivotally coupled to each other. As shown in the illustratedembodiment, the base portion 410 of the first hinge body 400 is integralwith the sleeve 62 such that the first hinge body 400 and the sleeve 62are monolithic. In another embodiment the base portion 410 includes arecess configured to at least partially receive the sleeve 62. Inanother embodiment, the base portion 410 includes a post configured tobe at least partially received within the bore 88 of the sleeve. Inanother embodiment, the sleeve 62 and the base portion 410 can includematching pin holes configured to be aligned and then receive a pin asdescribed in detail above in reference to the first joint 64.

Referring to FIGS. 6A and 6B, in one embodiment the strut 24 can beassembled as described below. The threaded rod 60 is inserted into thebore 88 of the sleeve 62 such that the follower 77 is at least partiallyreceived within the track 89. Once the threaded rod 60 is positionedwithin the sleeve 62 as described, the threaded rod 60 and the sleeve 62are translatable relative to each other along the strut axis 72, butthey are not rotatable relative to each other about the strut axis 72.The bearing 190 is attached to the sleeve outer surface 92 such that thebearing 190 and the sleeve 62 are rotationally and translationallycoupled relative to one another. For example the threaded inner surface264 of the bearing can be threadedly engaged with the threaded sleeveouter surface 92. The threaded rod 60 passes through the bearing bore198 such that the threaded rod 60 is translatable relative to thebearing 190.

The actuator 32 is attachable to the strut 24 such that the bearing 190is at least partially received within the bore 118 of the distractionnut 96 such that the bearing 190 is rotatable relative to thedistraction nut 96 about the strut axis 72. The drive nut 98 isattachable to the distraction nut 96 such that the drive nut 98 and thedistraction nut are translationally and rotationally coupled to eachother. When the drive nut 98 and the distraction nut 96 are attached asdescribed above, the bearing 190 is positioned within the first portion160 of the bore 118 of the distraction nut 96, such that the bearing istranslationally secured relative to the actuator 32 along the strut axis72 and rotatable about the strut axis 72 relative to the actuator 32.

The drive nut 98 is configured to be placed in the closed configurationby moving the clamp 288 into the first position such that the colletportion 274 is compressed and threaded inner surface 284 of the flexiblefingers 280 threadedly engages the threaded outer surface 80 of thethreaded rod 60. In the closed configuration rotation of the drive nut98 relative to the threaded rod 60 about the strut axis 72 translatesthe drive nut 98 relative to the threaded rod 60 along the strut axis72. The clamp 288 can be moved into the second position placing thedrive nut 98 in the open configuration such that the threaded innersurface 284 of the flexible fingers 280 does not threadedly engage thethreaded outer surface 80 of the threaded rod 60. In the openconfiguration the drive nut 98 is translatable relative to the threadedrod 60 along the strut axis 72 without rotating the drive nut 98relative to the threaded rod 60 about the strut axis 72.

The first joint 64 is attachable to the rod proximal end 74 such thatthe first hinge body 300 is both translationally (along the strut axis72) and rotatably (about the strut axis 72) coupled to the threaded rod60. The second joint 66 is attachable to the sleeve distal end 84 suchthat the first hinge body 400 is both translationally (along the strutaxis 72) and rotatably (about the strut axis 72) coupled to the sleeve62.

Referring to FIGS. 9A to 10B, the strut 24 defines a length L1 measuredfrom a first point on the strut 24 to a second point on the strut 24. Asshown in the illustrated embodiment, the length L1 is measured from thecross coupling member 304 of the first joint 64, specifically a center340 of the cross coupling member 304, along the strut axis 72, to thecross coupling member 404 of the second joint 66, specifically a center440 of the cross coupling member 404. The length L1 of the strut 24 isadjustable between a minimum length (as shown in FIGS. 9A and 9B) and amaximum length (as shown in FIGS. 10A and 10B). The length L1 isadjustable by actuation of the actuator 32. The actuation of theactuator 32 can include translation along the strut axis 72, rotationabout the strut axis 72, or both relative to the threaded rod 60.

To change the length L1 of the strut 24, the locking mechanism 104 ismoved from the first, locked configuration to the second unlockedconfiguration. For example, an applied force is exerted by a user on thebase portion 186 of the lever 106. The applied force is greater than thebiasing force applied by the spring 184 on the base portion 186, and theapplied force is applied in substantially the opposite direction of thebiasing force of the spring 184. Application of the applied force asdescribed above pivots the lever 106 about the pivot axis 178. As thelever 106 pivots about the pivot axis 178, the stop portion 188 of thelever 106 moves out of engagement with the recess 270 of the bearing190. When the stop portion 188 is removed from the recess 270, thelocking mechanism 104 is in the second, unlocked configuration and theactuator 32 is now rotatable relative to the threaded rod 60 about thestrut axis 72.

Once the actuator 32 has been rotated in a first direction, for examplecounter-clockwise, such that the stop portion 188 of the lever 106 is nolonger aligned with the recess 270, the applied force can be removedfrom the base portion 186. A torque applied to the gripping member 100,for example to the projection 166, in one embodiment specifically to oneof the projection side walls 170, rotates the actuator relative to thethreaded rod 60. Because the actuator 32 is translationally coupled tothe outer surface, rotation of the actuator 32 translates the threadedrod 60 relative to the actuator 32 and the sleeve 62 changing the lengthL1 as measured between the cross coupling members 304 and 404 of thefirst and second joints 64 and 66.

Upon the completion of a full rotation (360 degrees) about the strutaxis 72, the stop portion 188 of the lever 106 moves into alignment withthe recess 270 of the bearing 190. Once the stop portion 188 and recess270 are aligned, the biasing force of the spring 184 pivots the lever106 about the pivot axis 178 until the stop portion 188 is at leastpartially received within the recess 270. When the stop portion 188 isat least partially received within the recess 270 the locking mechanism104 is once again in the first, locked configuration and furtherrotation of the actuator 32 relative to the threaded rod 60 about thestrut axis 72 is prevented by interference between the stop portion 188and the locking feature 268. In one embodiment, the stop portion 188 andthe locking feature 268 include opposed surfaces, for example first andsecond surfaces. The opposed surfaces are configured such that no amountof torque applied by hand to the locking mechanism 104 about the strutaxis 72 will cause the opposed surfaces to cam over one another.

In one embodiment, the opposed surfaces are planar and substantiallyparallel to one another. In another embodiment the opposed (first andsecond) surfaces are substantially perpendicular to the strut axis. Asthe locking mechanism 104 rotates back into the first, lockedconfiguration an audible indication, for example a “click” is producedto alert a user to the completion of a revolution of the actuator 32 andconfirm that the locking mechanism 104 is once again in the first,locked configuration. In another embodiment, as the locking mechanism104 rotates back into the first, locked configuration a visualindication, a tactile indication, or both are produced, either insteadof or in addition to the audible indication, to alert a user to thecompletion of a revolution of the actuator 32 and confirm that thelocking mechanism 104 is once again in the first, locked configuration.

As shown, the locking mechanism 104 is configured such that the biasingforce of the spring 184 is applied to the base portion 186 in adirection that is angularly offset from the direction of elongation ofthe strut 24, or the strut axis 72 in the illustrated embodiment. Theangular offset of the biasing force relative to the strut axis 72, shownin the illustrated embodiment, prevents the application of a torque tothe actuator 32 from rotating the actuator 32 relative to the threadedrod 60 when the locking mechanism 104 is in the first, lockedconfiguration. Thus, in the illustrated embodiment, only when thelocking mechanism 104 is in the second, unlocked configuration does theapplication of a torque to the actuator 32 rotate the actuator 32relative to the threaded rod 60.

The strut 24 is configured such that a single rotation (360 degrees) ofthe actuator 32 relative to the threaded rod 60, translates the threadedrod 60 a predetermined amount relative to the sleeve 62. Thus a singlerotation of the actuator 32 relative to the threaded rod 60, changes thelength L1 a predetermined amount. The predetermined amount can beadjusted, for example by selecting a pitch for the corresponding threadsof the actuator 32 and the threaded rod 60. In one embodiment, a singlerotation of the actuator 32 relative to the threaded rod 60, changes thelength L1 of the strut 24 by 1 millimeter (mm).

Referring to FIGS. 6A-6B to 9A-10B, in one embodiment the strut 24includes a length indicator 500. The length indicator 500 is configuredto provide a visual indication of the length L1 of the strut 24. Asshown in the illustrated embodiment the length indicator 500 includes aclip 502 that is configured to be coupled to the threaded rod 60 suchthat clip 502 is translationally secured relative to the threaded rod 60and rotatable about the strut axis 72 relative to the threaded rod 60.The length indicator 500 can include a pin 504, such that the clip 502is configured to be attached by the pin 504 to the rod distal end 76.The clip 502 can include a post 506 that extends at least partiallythrough the slot 94 of the sleeve 62 when the clip is attached to thethreaded rod 60 and the threaded rod 60 is positioned at least partiallywithin the bore 88 of the sleeve 62. The length indicator 500 canfurther include markings 508 (as shown in FIG. 9A) on the sleeve outersurface 92. The markings 508 can be configured such that as the threadedrod 60 translates within the bore 88 of the sleeve 62, the clip 502which is attached to the threaded rod 60, is positioned adjacent amarking that indicates the current length L1 of the strut 24.

Referring to FIGS. 1A-2B and 5A-6B, in one embodiment, the device 20 isconfigured such that when one of the first and second end portions 26and 28 of the strut 24 is attached to one of the bases 22 the strut 24is rotatable about the strut axis 72 relative to the attached base 22,for example a hole 50 of the attached base 22. In another embodiment,the device 20 is configured such that when the first end portion 26 isattached to one of the bases 22, and the second end portion 28 isattached to another of the bases 22, the strut 24 is rotationally lockedrelative to the bases 22, such that the strut is not rotatable about thestrut axis 72 relative to the attached base 22, for example a hole 50 ofthe attached base 22.

In one embodiment, the device 20 includes the strut 24 having the firstjoint 64, the second joint 66, and the length L1 measured from the firstjoint 64 to the second joint 66 along a strut axis 72. The first andsecond joints 64 and 66 defining first and second fastener receivingholes 350 and 450 respectively, that are each configured to receive afastener 14 that is configured to secure the strut 24 to a base 22. Thestrut 24 includes the actuator 32 configured to adjust the length L1,and a locking mechanism 104. The locking mechanism is configured to besupported by the actuator 32, and the locking mechanism 104 includes alocked configuration in which the actuator 32 is prevented fromadjusting the length L1, and an unlocked configuration in which theactuator 32 is able to adjust the length L1.

The device 20 further can include first and second external bonefixation members, such as bases 22 a and 22 b. Each of the first andsecond external bone fixation members includes a first side wall 44 (oran inner surface) and a second side wall 46 (or an outer surface) thatis opposite the first side wall 44. The first side wall 44 defines aspace configured to receive the bone 2. The first and second bases 22each further include a top (or first) surface 38 and a bottom (orsecond) surface 40 that each extends between the respective first andsecond side walls 44 and 46. The bases 22 each further including a hole50 extending from the top surface 38 to the bottom surface 40, the hole50 configured to receive a fastener 14 to attach the strut 24 to thebase 22. The first side wall 44 defines an opening 48 configured toreceive the bone 2, and the base 22 defines a center 49 and a radialoutward direction that extends from the center 49 to the hole 50(“fastener receiving hole”) that receives a fastener 14 to attach thestrut 24 to the base 22.

A method of assembling the external bone fixation device 20 according toany of the embodiments disclosed herein is described below. The strut 24can be positioned relative to the first external bone fixation member(for example the first base 22 a) such that the fastener receiving hole350 of the first joint 64 is aligned with the fastener receiving hole 50of the first base 22 a. A first fastener 14 is inserted into and atleast partially through the fastener receiving hole 350 of the firstjoint 64 and the fastener receiving hole 50 of the first base 22 a, suchthat at least a portion of the strut 24, for example the actuator 32, isrotatable about the strut axis 72 relative to the fastener receivinghole 50 of the first base 22 a. The actuator 32 can be rotated about thestrut axis 72 relative to the fastener receiving hole 50 of the firstbase 22 a such that the locking mechanism 104 is spaced from the strutaxis 72 in a radially outward direction (a direction from the center 49to the fastener receiving hole 50 of the first base 22 a). In otherwords at least a portion of the strut 24, for example the actuator 32,is rotated such that the locking mechanism 104 faces outward from theopening 48 and the bone 2. The strut 24 is positioned relative to thesecond external bone fixation member (for example the base 22 b) suchthat the fastener receiving hole 450 of the second joint 66 is alignedwith the fastener receiving hole 50 of the second base 22 b. A secondfastener 14 is inserted into and at least partially through the fastenerreceiving hole 450 of the second joint 66 and the fastener receivinghole 50 of the second base 22 b. Wherein after both of the fasteners 14have been inserted into the respective fastener receiving holes, theportion of the strut 24, for example the actuator 32, is not rotatablerelative to the fastener fixation hole 50 of the first base 22 a aboutthe strut axis 72 when the locking mechanism 104 is in the lockedconfiguration.

In another embodiment, the method of assembling the external bonefixation device 20 according to any of the embodiments disclosed hereinincludes, positioning the strut 24 relative to the second external bonefixation member (for example the second base 22 b) such that thefastener receiving hole 350 of the first joint 64 is aligned with thefastener receiving hole 50 of the second base 22 b. A first fastener 14is inserted into and at least partially through the fastener receivinghole 350 of the first joint 64 and the fastener receiving hole 50 of thesecond base 22 b, such that at least a portion of the strut 24, forexample the actuator 32, is rotatable about the strut axis 72 relativeto the fastener receiving hole 50 of the second base 22 b. The actuator32 can be rotated about the strut axis 72 relative to the fastenerreceiving hole 50 of the second base 22 b such that the lockingmechanism 104 is spaced from the strut axis 72 in a radially outwarddirection (a direction from the center 49 to the fastener receiving hole50 of the second base 22 b). In other words at least a portion of thestrut 24, for example the actuator 32, is rotated such that the lockingmechanism 104 faces outward from the opening 48 and the bone 2. Thestrut 24 is positioned relative to the first external bone fixationmember (for example the base 22 b) such that the fastener receiving hole450 of the second joint 66 is aligned with the fastener receiving hole50 of the first base 22 a. A second fastener 14 is inserted into and atleast partially through the fastener receiving hole 450 of the secondjoint 66 and the fastener receiving hole 50 of the first base 22 a.Wherein after both of the fasteners 14 have been inserted into therespective fastener receiving holes, the portion of the strut 24, forexample the actuator 32, is not rotatable relative to the fastenerfixation hole 50 of the second base 22 b about the strut axis 72 whenthe locking mechanism 104 is in the locked configuration.

In another embodiment, the method of assembling the external bonefixation device 20 according to any of the embodiments disclosed hereinincludes, positioning the strut 24 relative to one of the external bonefixation member (for example the first base 22 a) such that the fastenerreceiving hole 450 of the second joint 66 is aligned with the fastenerreceiving hole 50 of the first base 22 a. The actuator 32 can be rotatedabout the strut axis 72 relative to the fastener receiving hole 50 ofthe first base 22 a such that the locking mechanism 104 is spaced fromthe strut axis 72 in a radially outward direction (a direction from thecenter 49 to the fastener receiving hole 50 of the first base 22 a). Inother words at least a portion of the strut 24, for example the actuator32, is rotated such that the locking mechanism 104 faces outward fromthe opening 48 and the bone 2. A first fastener 14 is inserted into andat least partially through the fastener receiving hole 450 of the secondjoint 66 and the fastener receiving hole 50 of the first base 22 a, suchthat at least a portion of the strut 24, for example the actuator 32, isnot rotatable about the strut axis 72 relative to the fastener receivinghole 50 of the first base 22 a when the locking mechanism 104 is in thelocked configuration. A second fastener 14 is inserted into and at leastpartially through the fastener receiving hole 350 of the first joint 66and the fastener receiving hole 50 of the second base 22 b.

In another embodiment, the method of assembling the external bonefixation device 20 according to any of the embodiments disclosed hereinincludes, positioning the strut 24 relative to one of the external bonefixation member (for example the second base 22 b) such that thefastener receiving hole 450 of the second joint 66 is aligned with thefastener receiving hole 50 of the second base 22 b. The actuator 32 canbe rotated about the strut axis 72 relative to the fastener receivinghole 50 of the second base 22 b such that the locking mechanism 104 isspaced from the strut axis 72 in a radially outward direction (adirection from the center 49 to the fastener receiving hole 50 of thesecond base 22 b). In other words at least a portion of the strut 24,for example the actuator 32, is rotated such that the locking mechanism104 faces outward from the opening 48 and the bone 2. A first fastener14 is inserted into and at least partially through the fastenerreceiving hole 450 of the second joint 66 and the fastener receivinghole 50 of the second base 22 b, such that at least a portion of thestrut 24, for example the actuator 32, is not rotatable about the strutaxis 72 relative to the fastener receiving hole 50 of the second base 22b when the locking mechanism 104 is in the locked configuration. Asecond fastener 14 is inserted into and at least partially through thefastener receiving hole 350 of the first joint 66 and the fastenerreceiving hole 50 of the first base 22 a.

In one embodiment the external bone fixation device 20 includes a kithaving a plurality of struts 24 and a plurality of bases 22. The kit canfurther include a plurality of attachment mechanisms 200. In anotherembodiment, the plurality of struts 24 includes struts with differentminimum and maximum lengths L1 (measured, for example, from the center340 of the cross coupling member 304 of the first joint 64 to the center440 of the cross coupling member 440 of the second joint 66). Theplurality of struts 24 in the kit, in one embodiment, can include anycombination of one or more extra short struts, one or more short struts,one or more medium struts, and one or more long struts. In anotherembodiment the extra short struts define a minimum length L1 of about 91mm and a maximum length L1 of about 121 mm for a total travel distanceof about 30 mm. In another embodiment the short struts define a minimumlength L1 of about 116 mm and a maximum length L1 of about 152 mm for atotal travel distance of about 36 mm. In another embodiment the mediumstruts define a minimum length L1 of about 142 mm and a maximum lengthL1 of about 205 mm for a total travel distance of about 63 mm. Inanother embodiment the long struts define a minimum length L1 of about195 mm and a maximum length L1 of about 311 mm for a total traveldistance of about 116 mm.

The plurality of bases 22 in the kit, in one embodiment, can include anycombination of one or more bases with an outer diameter of 90 mm, 120mm, 150 mm, 180 mm, 210 mm, and 240 mm. The plurality of attachmentmechanisms 200 in the kit, in one embodiment, can include anycombination of one or more brackets 202, fasteners 206, wires 208 androds 210.

It will be appreciated by those skilled in the art that changes could bemade to the embodiments described above without departing from the broadinventive concept thereof. It is understood, therefore, that thisdisclosure is not limited to the particular embodiments disclosed, butit is intended to cover modifications within the spirit and scope of thepresent disclosure as defined by the claims.

1. (canceled)
 2. A method of assembling an external bone fixationdevice, the method comprising the steps of: positioning a strut relativeto a first external bone fixation member such that a fastener receivinghole of a first joint of the strut is aligned with a fastener receivinghole of the first external bone fixation member; inserting a fastenerinto and at least partially through the fastener receiving hole of thefirst joint and the fastener receiving hole of the first external bonefixation member; rotating the strut relative to the fastener receivinghole of the first external bone fixation member about a strut axis,which the strut is elongate along; positioning the strut relative to asecond external bone fixation member such that a fastener receiving holeof a second joint of the strut is aligned with a fastener receiving holeof the second external bone fixation member; inserting a second fastenerinto and at least partially through the fastener receiving hole of thesecond joint and the fastener receiving hole of the second external bonefixation member; wherein after the step of inserting the second fastenerinto and at least partially through the fastener receiving holes of thesecond joint and the second external bone fixation member, an actuatorof the strut is not rotatable relative to the fastener receiving hole ofthe first external bone fixation member about the strut axis when alocking mechanism of the strut is in a locked configuration in which theactuator is prevented from adjusting a length of the strut measured fromthe first joint to the second joint along the strut axis.
 3. The methodof claim 2, wherein the first external bone fixation member defines acenter and a radial outward direction that extends from the center tothe fastener receiving hole of the first external bone fixation member,and the rotating step includes rotating the strut until the lockingmechanism is spaced from the strut axis in the radial outward direction.4. The method of claim 2, further comprising the steps of: positioning asecond strut relative to the first external bone fixation member suchthat a fastener receiving hole of a first joint of the second strut isaligned with a second fastener receiving hole of the first external bonefixation member; inserting a third fastener into and at least partiallythrough the fastener receiving hole of the first joint of the secondstrut and the second fastener receiving hole of the first external bonefixation member; rotating the second strut relative to the secondfastener receiving hole of the first external bone fixation member abouta second strut axis, which the second strut is elongate along;positioning the second strut relative to the second external bonefixation member such that a fastener receiving hole of a second joint ofthe second strut is aligned with a second fastener receiving hole of thesecond external bone fixation member; inserting a fourth fastener intoand at least partially through the fastener receiving hole of the secondjoint of the second strut and the second fastener receiving hole of thesecond external bone fixation member; wherein after the step ofinserting the fourth fastener into and at least partially through thefastener receiving hole of the second joint of the second strut and thesecond fastener receiving hole of the second external bone fixationmember, an actuator of the second strut is not rotatable relative to thesecond fastener receiving hole of the first external bone fixationmember about the second strut axis when a locking mechanism of thesecond strut is in a locked configuration in which the actuator of thesecond strut is prevented from adjusting a length of the second strutmeasured from the first joint of the second strut to the second joint ofthe second strut along the second strut axis.
 5. The method of claim 4,wherein the first external bone fixation member defines a center and aradial outward direction that extends from the center to the fastenerreceiving hole of the first external bone fixation member, and the stepof rotating the strut includes rotating the strut until the lockingmechanism is spaced from the strut axis in the radial outward direction.6. The method of claim 5, wherein the step of rotating the second strutincludes rotating the second strut until the locking mechanism of thesecond strut is spaced from the second strut axis in the radial outwarddirection.
 7. A method of adjusting a length of a strut body of a strutfrom a first joint to a second joint that is spaced from the first jointalong an axis, wherein the first joint is carried by a threaded rod ofthe strut body and is attached to a first external bone fixation member,and the second joint is carried by a sleeve of the strut body and isattached to a second external bone fixation member, the methodcomprising the steps of: applying a force to a locking mechanism of thestrut along a direction offset with respect to the strut axis, so as toiterate the locking mechanism from a locked configuration to an unlockedconfiguration, whereby when the locking mechanism is in the lockedconfiguration, an actuator of the strut, that is configured to rotaterelative to the strut body so as to cause the strut body to change inlength, is rotatably fixed to the strut body, and when the lockingmechanism is in the unlocked configuration, the actuator is rotatablewith respect to the strut body; after the applying step, rotating theactuator of the strut about the strut axis relative to the strut body,thereby causing at least one of the threaded and the sleeve of the strutbody to translate relative to the other of the threaded rod and thesleeve along the strut axis.
 8. The method of claim 7, wherein themoving step includes the step of pivoting the locking mechanism about apivot axis.
 9. The method of claim 8, wherein the pivoting step includesthe step of applying a force to the locking mechanism in a directionthat is offset with respect to both the strut axis and the pivot axis.10. The method of claim 9, wherein the applying step includes the stepof removing a portion of the locking mechanism from a recess of thestrut, and the rotating step is performed after the applying step. 11.The method of claim 10, wherein the applying step includes the step ofcompressing a spring.
 12. The method of claim 11, further comprising thestep of removing the force from the locking mechanism thereby allowingthe spring to expand, wherein the removing step is performed after therotating step.
 13. The method of claim 12, further comprising a secondstep of rotating the actuator of the strut relative to the strut bodyabout the strut axis, thereby causing at least one of a threaded rod ofthe strut body and a sleeve of the strut body to translate relative tothe other of the sleeve and the threaded rod along the strut axis,wherein the second rotating step is performed after the removing step.14. The method of claim 13, wherein the first rotating step includesrotating the actuator of the strut relative to the strut body about thestrut axis in a first direction, and the second rotating step includesrotating the actuator of the strut relative to the strut body about thestrut axis in the first direction.
 15. The method of claim 14, furthercomprising the step of aligning the portion of the locking mechanismwith the recess thereby allowing the spring to expand and bias theportion of the locking mechanism into the recess.
 16. The method ofclaim 15, wherein the aligning step includes the spring biasing theportion of the locking mechanism into the recess thereby producing anaudible indication.
 17. The method of claim 15, wherein the aligningstep includes the step of moving a surface of the portion to face asurface of the strut that partially defines the recess such that noamount of torque applied by hand to the locking mechanism about thestrut axis will cause the surface of the portion and the surface of thestrut to cam over one another.
 18. A method of assembling an externalbone fixation device configured to repair a deformity in a bone, theexternal bone fixation device including: (1) a strut having a firstjoint, a second joint, and a length measured from the first joint to thesecond joint along a strut axis, the first and second joints definingfirst and second fastener receiving holes respectively, the strutfurther including an actuator configured to adjust the length, and alocking mechanism configured to be supported by the actuator, thelocking mechanism including a locked configuration in which the actuatoris prevented from adjusting the length, and an unlocked configuration inwhich the actuator is able to adjust the length; and (2) first andsecond external bone fixation members, each of the first and secondexternal bone fixation members including a top surface and a bottomsurface that each extends between the respective inner and outersurfaces, the first and second external fixation members each furtherincluding a fastener receiving hole extending from the top surface tothe bottom surface, wherein the first external fixation member defines acenter and a radial outward direction that extends from the center tothe fastener receiving hole of the first external bone fixation member,the method comprising: positioning the strut relative to the firstexternal bone fixation member such that the fastener receiving hole ofthe first joint is aligned with the fastener receiving hole of the firstexternal fixation member; inserting a first fastener into and at leastpartially through the fastener receiving hole of the first joint and thefastener receiving hole of the first external bone fixation member;rotating the actuator about the strut axis relative to the fastenerreceiving hole of the first external bone fixation member such that thelocking mechanism is spaced from the strut axis in the radial outwarddirection; positioning the strut relative to the second external bonefixation member such that the fastener receiving hole of the secondjoint is aligned with the fastener receiving hole of the second externalbone fixation member; inserting a second fastener into and at leastpartially through the fastener receiving hole of the second joint andthe fastener receiving hole of the second external bone fixation member;wherein after the step of inserting the second fastener into and atleast partially through the fastener receiving holes of the second jointand the second external bone fixation member, the actuator is notrotatable relative to the fastener receiving hole of the first externalbone fixation member about the strut axis when the locking mechanism isin the locked configuration.
 19. The method of claim 18, wherein thestrut is a first strut, the external bone fixation device includes: (1)a second strut having a first joint, a second joint, and a lengthmeasured from the first joint of the second strut to the second joint ofthe second strut along a strut axis of the second strut, the first andsecond joints of the second strut defining first and second fastenerreceiving holes respectively, the second strut further including anactuator configured to adjust the length of the second strut, and alocking mechanism configured to be supported by the actuator of thesecond strut, the locking mechanism of the second strut including alocked configuration in which the actuator of the second strut isprevented from adjusting the length of the second strut, and an unlockedconfiguration in which the actuator of the second strut is able toadjust the length of the second strut, and the method further includesthe steps of: positioning the second strut relative to the firstexternal bone fixation member such that the fastener receiving hole ofthe first joint of the second strut is aligned with a second fastenerreceiving hole of the first external fixation member; inserting a thirdfastener into and at least partially through the fastener receiving holeof the first joint of the second strut and the second fastener receivinghole of the first external bone fixation member; rotating the actuatorof the second strut about the strut axis of the second strut relative tothe second fastener receiving hole of the first external bone fixationmember such that the locking mechanism of the second strut is spacedfrom the strut axis of the second strut in the radial outward direction;positioning the strut relative to the second external bone fixationmember such that the fastener receiving hole of the second joint isaligned with the fastener receiving hole of the second external bonefixation member; inserting a second fastener into and at least partiallythrough the fastener receiving hole of the second joint and the fastenerreceiving hole of the second external bone fixation member; whereinafter the step of inserting the second fastener into and at leastpartially through the fastener receiving holes of the second joint andthe second external bone fixation member, the actuator is not rotatablerelative to the fastener receiving hole of the first external bonefixation member about the strut axis when the locking mechanism is inthe locked configuration.